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FDA 510(k)

LC Bead LUMI

K-Number: K162373 · 2016-12-16

ApplicantBiocompatibles UK Limited
Decision Date2016-12-16
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LC Bead LUMI is a medical device manufactured by Biocompatibles UK Limited. It received FDA 510(k) clearance on 2016-12-16 under approval number K162373. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LC Bead LUMI?

LC Bead LUMI is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Biocompatibles UK Limited. The 510(k) number is K162373.

When was LC Bead LUMI approved by the FDA?

LC Bead LUMI received FDA 510(k) clearance on 2016-12-16, under approval number K162373.

What company makes LC Bead LUMI?

LC Bead LUMI is manufactured by Biocompatibles UK Limited.

What is the FDA product code for LC Bead LUMI?

The FDA product code for LC Bead LUMI is KRD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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